The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...

GSK's revenue and EPS exceeded my expectations and those of analysts. Check out the reasons why I am upgrading GSK stock's ...

We support drug discovery and cell medicine development by providing iPS cells and other cell products that meet PMDA and FDA standards to pharmaceutical and cell medicine development companies so ...

It is well known that HLA homozygous iPSCs are often selected to reduce adverse immune response in patients, however, there has recently been an increased demand for type O female blood-derived iPSCs.

Discover Stoke Therapeutics' innovative RNA-based treatments like zorevunersen for Dravet syndrome, with a promising pipeline ...

CRO" running radically faster, more reliable clinical trials, has announced their collaboration with the Clinical Data Interchange Standards Consortium (CDISC), to accelerate the generation of ...

In April this year Renalys submitted an Investigational New Drug (IND) Application for sparsentan to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan ... In 2023, Travere received FDA ...

The adoption of these standards is driven by regulators such as FDA and PMDA, who mandate that data must be submitted in these formats. This post gives a very brief overview of each model ...

This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM. This post shines a spotlight on ...

In a recent transaction, Peter Altman, President and CEO of BioCardia, Inc. (NASDAQ:BCDA), purchased 600 shares of the company's common stock. The shares were acquired at an average price of $2.48 per ...